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Diagnosis of cancer by detecting auto-antibodies against EGF-receptor

a technology of egf receptor and auto-antibodies, which is applied in the field of epithelial cancer diagnosis, prognosis and treatment of ovarian cancer, can solve the problems of affecting the prognosis of cytoreductive surgery in patients with advanced epithelial ovarian cancer, affecting the prognosis of ovarian cancer, so as to achieve high egfr antibody levels

Active Publication Date: 2020-08-11
CELLTREND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent is about a method for diagnosing and predicting the response of cancer to treatment. The method involves measuring the level of antibodies against epidermal growth factor receptor (EGFR) in a sample from the subject to be diagnosed. If the level of antibodies is decreased compared to a control level, it indicates cancer. The method can also be used to predict whether the subject will respond or not to a specific treatment. The invention is based on the finding that levels of antibodies against EGFR are diagnostic and predictive of cancer and response to treatment.

Problems solved by technology

Serum CA125 levels may be falsely elevated in women with any i.p. pathology resulting in irritation of the serosa of the peritoneum or pericardium, uterine fibroids, renal disorders, and normal menses.
Moreover, serum CA125 levels do not predict the outcome of cytoreductive surgery in patients with advanced epithelial ovarian cancer.
If the cancer isn't accurately staged, then cancer that has spread outside the ovary might be missed and not treated.

Method used

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  • Diagnosis of cancer by detecting auto-antibodies against EGF-receptor
  • Diagnosis of cancer by detecting auto-antibodies against EGF-receptor
  • Diagnosis of cancer by detecting auto-antibodies against EGF-receptor

Examples

Experimental program
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Effect test

example 1

[0096]We measured the anti-EGFR autoantibody in serum samples using a sandwich ELISA kit (CellTrend GmbH Luckenwalde, Germany). The microtiter 96-well polystyrene plates were coated with membrane extracts of a cancer cell line “A431” human EGFR of SEQ ID NO:1. To maintain the conformational epitopes of the receptor, 1 mM calcium chloride was added to every buffer. Duplicate samples of a 1:100 serum dilution were incubated at 4° C. for 2 hours. After washing steps, plates were incubated for 60 minutes with a 1:20.000 dilution of horseradish-peroxidase—labeled goat anti-human IgG (Jackson, USA) used for detection. In order to obtain a standard curve, plates were incubated with test sera from an anti-EGFR autoantibody positive index patient. The ELISA was validated according to the FDA's “Guidance for industry: Bioanalytical method validation”.

[0097]To set a standard for the concentrations of the autoimmuno antibodies, a standard curve was generated In detail, a serum sample of a syste...

example 2

[0098]Anti-EGFR antibody levels in serum samples from 131 healthy donors (“control”) and 201 patients with ovarian cancer (“case”) were measured using the kit and method of Example 1. The levels were determined in units / mL. FIG. 1 shows the mean values of the natural logarithm of the EGFR antibody level for case and control subjects. Patient suffering from ovarian cancer had significantly lower levels (p≤0.0001) of anti-EGFR antibodies as compared to healthy controls.

example 3

[0099]Levels of the EGFR-antibody were compared in patients showing relapse of ovarian cancer after therapy and patients showing no relapse. Treatment was surgical removal of the tumor and subsequent chemotherapy with cis platinum or carboplatinum conducted and monitored by physicians. Samples of patients were taken before treatment. Patients were categorized as “relapse” or “no relapse” according to the reoccurrence of cancer after a period of 24 months. Levels of EGFR-antibody were determined as outlined in Example 1. EGFR-AA levels are significantly higher in patients who had no relapse, compared to patients who had a relapse (p=0.0044). The determined levels were also compared to the control group of healthy subjects. These results are shown in FIG. 2.

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Abstract

The present invention relates to a method for diagnosis of a cancer, comprising the steps of (i) determining the level of antibodies against epidermal growth factor receptor (EGFR) in a sample from a subject to be diagnosed, (ii) comparing the determined level in the sample to a control level derived from subjects without cancer; wherein a decreased level in the sample from the subject to be diagnosed as compared to the control level is indicative for cancer in the subject. Furthermore, the invention relates to method of predicting response and outcome of a treatment of a cancer with an inhibitor of EGFR activity.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a national stage application under 35 U.S.C. § 371, and claims priority to and the benefit of the filing date of International Application Number PCT / EP2015 / 052181, filed Feb. 3, 2015, which is herein incorporated in its entirety.REFERENCE TO A SEQUENCE LISTING SUBMITTED AS A TEXT FILE VIA EFS-WEB[0002]The Sequence Listing submitted Aug. 3, 2016 as a text file named “31904_111942_1U1_SeqListing.txt”, created on Aug. 3, 2016, and having size of 12,288 bytes is hereby incorporated by reference pursuant to 37 C.F.R. § 1.52(e)(5).FIELD OF THE INVENTION[0003]The present invention is in the field of diagnostics, prognosis and therapeutics for cancer, more in particular in the field of diagnosis and therapy of epithelial cancer, more particular in the field of diagnosis, prognosis and therapy of ovarian cancer.BACKGROUND OF THE INVENTION[0004]According to the American Cancer Society ovarian cancer is expected to account for o...

Claims

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Application Information

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Patent Type & Authority Patents(United States)
IPC IPC(8): G01N33/574C07K16/28G01N33/74A61K39/00G01N33/564
CPCC07K16/2863G01N33/74G01N33/564G01N33/57488G01N33/57449G01N2800/54G01N2333/71G01N2333/485A61K2039/505C07K2317/76C07K2317/24G01N2800/52
Inventor HEIDECKE, HARALDSCHULZE-FORSTER, KAI
Owner CELLTREND
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